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Outcomes of Asthma

Outcomes of Asthma. A. Sonia Buist M.D. Oregon Health & Science University, Portland, Oregon. OUTCOMES. Markers of success or failure in managing a disease, focused on the important characteristics that influence the course and consequences of that disease for patients and society

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Outcomes of Asthma

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  1. Outcomes of Asthma A. Sonia Buist M.D. Oregon Health & Science University, Portland, Oregon

  2. OUTCOMES • Markers of success or failure in managing a disease, focused on the important characteristics that influence the course and consequences of that disease for patients and society • Meaningful correlation with benefit • Outcome must be measurable • Outcome must be amenable/sensitive to change • Valid reflections of the process of care

  3. Asthma outcomes • Mortality • Prevalence • Hospital admissions & re-admissions • Heath resource utilisation & costs • Severity - Control • Morbidity • Time lost from school, work • Treatment impact • Doctor visits • QOL • Exacerbations

  4. Asthma Control as New Outcome for Asthma • FEV1 infrequently measured and doesn’t correlate well with health status • Adherence to peak flow monitoring poor • Need for a simple, inexpensive instrument that can be used in clinical practice and clinical research

  5. Goals of Asthma Management • Maintain “near normal” pulmonary function • Prevent chronic and troubling symptoms • Maintain normal activity levels • Prevent recurrent exacerbations • Minimal or no adverse effects of treatment National Asthma Education and Prevention Program Expert Panel (NAEPP) Report 2: Guidelines for the Diagnosis and Management of Asthma. Update on selected topics. Allergy Clin Immunol 2002;110(5 pt 2):S141-219.

  6. NAEPP Severity

  7. NAEPP Severity

  8. Stepwise Approach to Asthma Therapy - Adults Outcome: BestPossible Results Outcome: Asthma Control • Controller: • Daily inhaled corticosteroid • Daily long –acting inhaled β2-agonist • plus (if needed) • When asthma is controlled, reduce therapy • Monitor • Controller: • Daily inhaled corticosteroid • Daily long-acting inhaled β2-agonist • Controller: • Daily inhaled • corticosteroid Controller: None -Theophylline-SR -Leukotriene modifier -Oral corticosteroid Reliever: Rapid-acting inhaled β2-agonist prn STEP 1: Intermittent STEP 2:Mild Persistent STEP 3: Moderate Persistent STEP 4: Severe Persistent STEP Down Alternative controller and reliever medications may be considered

  9. Problems with Using Guideline-Defined Severity • Spirometry often not done • Patients are already on asthma meds (guidelines say “pre-drug”) • ICS affect lung function so hard to assess severity accurately • Lung function is measured at one point in time (not a composite measurement) • Severity is often underestimated

  10. What is Severity? Depends on your perspective

  11. What is Severity? To a Clinician: a patient who needs: • several different kinds of asthma medications • who goes to the ED frequently • who has low lung function that doesn’t reverse completely with short-acting bronchodilators

  12. What is Severity? To a Patient: asthma that seriously interferes with their life: • wakes them at night • needs several medications • involves a complicated management regimen • interferes with school/work • prevents them from doing what they would like to do

  13. What is Severity? To a Healthcare Manager: a patient who uses healthcare that is costly: • frequent ED visits/hospitalizations • needs a specialist • needs costly medications

  14. What is Severity? To a pathologist: very severe chronic inflammatory changes in the airways, probably with remodeling. To a physiologist: a patient with severe airflow limitation that is largely (but not necessarily entirely) reversible.

  15. Why is Severity Important? • Closely linked to cost-of-care • Enables targeted interventions • clinical trials • guidelines implementation

  16. Global severity Level of control Medical management Health outcomes • HCU • QOL • Factual • status Self- management Other personal factors Environmental exposures

  17. Alternative to Management Algorithm • Use asthma control as a guide rather than asthma severity SeverityControl

  18. Interplay of Asthma Severity, Management and Control Asthma management Good Poor Severe good control Severity poor control Mild Severe

  19. Red Flags That Asthma Is Not Well Controlled • Frequent use of short-acting beta-agonists • Use of >1 canister of SABA/month or >8 puffs/day • Need for unscheduled care (ED or hospitalization) • Missed school or work

  20. What Is Good Control? • Virtually no use of short-acting -agonist (<2x/week) • Isn’t woken at night by asthma • No unscheduled health care utilization (ED visits/hospitalization) • No lost work or school • No exacerbations

  21. Why is Level of Control Important? • Reflects patients current health status • Reflects outcome of care • Typically a very patient-oriented measure

  22. Which is More Important: Severity or Level of Control? • Depends on your perspective • Individual clinician: level of control is key • FDA/pharmaceutical industry • Health plan manager • Epidemiologist/ • outcomes researcher Level of control is outcome, severity is a confounder

  23. Control Instruments Available • ATAQ (Asthma Therapy Assessment Questionnaire). Cross-sectional & prospective validation 4 dimensions • ACQ (Asthma Control Questionnaire). Juniper 7 questions • ACT (Asthma Control Test—QualityMetric Inc) 5 dimensions

  24. Development & Validation of Asthma Therapy Assessment Questionnaire • We developed a simple 4-question instrument to assess asthma control • Scored as 0-4 (control problems) • Validated the instrument in a large health management organization (cross-sectional validation) • Prospectively validated the instrument over 12 months Vollmer et al, Am J Resp Crit Care Med 1999;160:1647-1652

  25. Asthma Therapy Control Questionnaire (ATAQ) • In the past 4 weeks, did you feel that your asthma was well controlled? • In the past 4 weeks, did you miss any work, school or normal activity because of your asthma? • In the past 4 weeks, did your asthma wake you up at night? • In the past 4 weeks, what was the highest # of puffs a day you took of your quick relief inhaler? Vollmer et al, Am J Resp Crit Care Med 1999;160:1647-1652 Score is 0-4

  26. ATAQ Asthma Control Index In the past four weeks (12 months): Has your asthma been well-controlled? Score 1 point if “no” or “unsure”

  27. ATAQ Asthma Control Index In the past four weeks (12 months): Has your asthma been waking you up at night? Score 1 point if “yes” or “unsure”

  28. ATAQ Asthma Control Index In the past four weeks (12 months): Has your asthma been interfering with your usual activities? Score 1 point if “yes” or “unsure”

  29. ATAQ Asthma Control Index In the past four weeks (12 months): What is the highest number of puffs of your reliever medication on any single day? Score 1 point if more than 12

  30. Cross-sectional validation of ATAQ • ATAQ mailed to 5,181 adult members of large health maintenance organization (HMO) in Pacific Northwest of U.S.(K.P.) • Quality of life instruments (generic [SF-36] and asthma-specific [Juniper]) also sent to one-quarter. Vollmer et al, Am J Resp Crit Care Med 1999;160:1647-1652

  31. Distribution of ATAQ Control Index Ref: Vollmer et al., AJRCCM 1999

  32. ATAQ Validation Within last Within last4 weeksyearSelf-perception of asthma control 30% - -Missed activities 27% 47%Nocturnal awakening 40% 66%Overuse of rescue meds 8% 15%At least one problem 52% - - Vollmer WM, et al. Am J Respir Crit Care Med. 1999;160:1647-1652.

  33. 0 80 1 70 2 60 3 50 4 40 30 20 10 0 Retrospective Validation of ATAQ Relation Between Control of Problems During Previous 4 Weeks & Health Care Utilization During Previous Year # of Problems with Asthma Control Patients (%) ≥2 Visits worsening ≥1 Urgent visit ≥1 Hospitalization asthma Within each control group, p<0.001 Vollmer et al. Am J Respir Crit Care Med. 1999;160:1647-1652.

  34. Mean Quality of Life Scores by Number of Control Problems Number of Control Problems in Past 4 Weeks Vollmer et al, Am J Resp Crit Care Med 1999;160:1647-52

  35. Association of Asthma Control with Health Care Utilization: A Prospective Evaluation • Prospectively validated control instrument (ATAQ) • Studied HCU over subsequent 12 months Vollmer et al, AJRCCM 2002; 165: 195-99

  36. 1600 200 1400 175 1200 150 1000 125 100 800 600 75 400 50 200 25 0 0 Prospective Validation of ATAQ 4795 Subjects with Asthma Who Completed ATAQ Followed Prospectively for 1 Year # of Problems with Asthma Control 0 1 2 Rate per 1000 Patient Years 3 or 4 Routine Visits Acute Visits ED Visits Hospitalizations Vollmer et al. Am J Respir Crit Care Med. 2002;165:195-199.

  37. Conclusions from ATAQ Validation • The majority of asthma patients are probably not in optimal control • Asthma control as assessed by the ATAQ can predict past & future health care utilization • ATAQ is simple to use & can be self-administered

  38. Assessing Outcomes of Care • Level of control can be viewed as a legitimate outcome in its own right • Can also be used to predict more traditional outcomes of care, such as health care utilization and quality of life

  39. Asthma Control : a worthy outcome? Ideal asthma control • Absent or minimal symptoms • Absent or minimal rescue medication • No nocturnal or early am symptoms • Absent morbidity • Lung function normal or best Professor Ann Woolcock

  40. Time course of asthma control No night symptoms am PEF 100 No SABA use FEV1 AHR % improvement 0 Days Weeks Months Years Woolcock AJ Clin Exp Allergy Rev, 2001. 1(2): p. 62-4.

  41. Gaining Optimal Asthma Control (GOAL) Study Background: “to date no studies have assessed the benefits of aiming for complete, comprehensive, and sustained clinical control in a controlled study that allows for dose escalation, as necessary, to achieve this”

  42. Gaining Optimal Asthma Control (GOAL) Study • 1-yr RCT with 3,421 pts aged 12-80 yrs from 44 countries with uncontrolled asthma • 2 arms: fluticasone + salmeterol and fluticasone alone • Treatment was stepped up until total control was reached (or 500µg CS bid) • Control assessed over 8wks before visits at 12,24,36 52 months Bateman et al AJRCCM 2004; 170: 836-44

  43. Gaining Optimal Asthma Control (GOAL) Study • 2 control definitions used: “totally controlled” and “well controlled”. If neither, “uncontrolled” • Control definitions were composite measures that included: PEF, rescue med use, symptoms, night-time wakenings, exacerbations, ED visits, adverse events Bateman et al AJRCCM 2004; 170: 836-44

  44. Bateman et al, Am J Resp Crit Care Med 2004;170:836-844.

  45. Outcomes of GOAL Study • Proportion of pts who achieved well-controlled asthma with the combo compared to fluticasone alone in phase 1 • Many secondary outcomes Bateman et al AJRCCM 2004; 170: 836-44

  46. Gaining Optimal Asthma Control (GOAL) Study Phase 1: Dose escalation. Regimen stepped up every 12 weeks until total control achieved or max dose Phase 2: Maintenance control dose or max dose for 1 year (double blind) Bateman et al AJRCCM 2004; 170: 836-44

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